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FDA 510(k) Application Details - K110420
Device Classification Name
More FDA Info for this Device
510(K) Number
K110420
Device Name
OPHIRA MINI SLING SYSTEM
Applicant
PROMEDON S.A.
221 ELLIS PARKWAY
PISCATAWAY, NJ 08854 US
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Contact
STEPHANIE RAIS
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PAH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2011
Decision Date
05/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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